Sulfoxaflor; Pesticide Tolerances for Emergency Exemptions, 59561-59566 [2012-23818]

Download as PDF Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations Parts per million Commodity * * * * Berry and small fruit, group 13–07 0.15 * * * * Vegetable, soybean, succulent .... 0.15 * * * * * * * * * * * * [FR Doc. 2012–23986 Filed 9–27–12; 8:45 am] BILLING CODE 6560–50–P I. General Information ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2012–0493; FRL–9361–4] Sulfoxaflor; Pesticide Tolerances for Emergency Exemptions Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes time-limited tolerances for residues of sulfoxaflor, N-methyloxido [1-[6(trifluoromethyl)-3-pyridinyl]ethyl] l4sulfanylidene] cyanamide, including its metabolites and degradates in or on cotton, undelinted seed; cotton, gin byproducts; and cotton, hulls. This action is in response to EPA’s granting of emergency exemptions under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on cotton. This regulation establishes maximum permissible levels for residues of sulfoxaflor in or on these commodities. These time-limited tolerances expire on December 31, 2015. DATES: This regulation is effective September 28, 2012. Objections and requests for hearings must be received on or before November 27, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2012–0493, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and mstockstill on DSK4VPTVN1PROD with RULES SUMMARY: VerDate Mar<15>2010 16:22 Sep 27, 2012 Jkt 226001 the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: 703–308–9364; email address: pemberton.libby@epa.gov. SUPPLEMENTARY INFORMATION: A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office’s e-CFR site at http:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. C. How can I file an objection or hearing request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2012–0493 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 27, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 59561 public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2012–0493, by one of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statue. • Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/ DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http:// www.epa.gov/dockets/contacts.htm. II. Background and Statutory Findings EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for combined residues of sulfoxaflor, N-methyloxido [1-[6(trifluoromethyl)-3-pyridinyl]ethyl] l4sulfanylidene] cyanamide, including its metabolites and degradates in or on cotton, undelinted seed at 0.2 parts per million (ppm); cotton, gin byproducts at 6.0 ppm; and cotton, hulls at 0.35 ppm. These time-limited tolerances expire on December 31, 2015. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ E:\FR\FM\28SER1.SGM 28SER1 59562 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.’’ Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ‘‘emergency conditions exist which require such exemption.’’ EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Sulfoxaflor for Various Commodities and FFDCA Tolerances The states of Arkansas, Mississippi, Tennessee, and Louisiana submitted emergency use requests for the use of the unregistered active ingredient, sulfoxaflor, on cotton to control the tarnished plant bug. The requests are a result of the resurgence of tarnished plant bug as a primary pest of cotton. The states assert growers are facing a longer control season for tarnished plant bug. In addition, tarnished plant bug has developed resistance to registered alternatives. After having reviewed the submissions, EPA determined that emergency conditions exist for these States, and that the criteria for emergency exemptions are met. EPA has authorized specific exemptions under FIFRA section 18 for the use of sulfoxaflor on cotton for control of tarnished plant bug in Arkansas, Mississippi, Tennessee, and Louisiana. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of sulfoxaflor in or on cotton. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing VerDate Mar<15>2010 16:22 Sep 27, 2012 Jkt 226001 this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although these time-limited tolerances expire on December 31, 2015, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on cotton, undelinted seed; cotton, ginbyproducts; and cotton, hulls after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether sulfoxaflor meets FIFRA’s registration requirements for use on cotton or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that these timelimited tolerances decision serves as a basis for registration of sulfoxaflor by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Arkansas, Mississippi, Tennessee, and Louisiana to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for sulfoxaflor, contact the Agency’s Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ‘‘safe.’’ Section 408(b)(2)(A)(ii) of FFDCA defines ‘‘safe’’ to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 chemical residue in establishing a tolerance and to ‘‘ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. * * *’’ Consistent with the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of these emergency exemption requests and the time-limited tolerances for combined residues of sulfoxaflor in or on cotton, undelinted seed at 0.2 parts per million (ppm); cotton, gin byproducts at 6.0 ppm; and cotton, hulls at 0.35 ppm. Use of cotton commodities conforming to these temporary tolerances as animal feed is not expected to produce sulfoxaflor residues in livestock commodities. EPA’s assessment of exposures and risks associated with establishing these timelimited tolerances follows. A. Toxicological Points of Departure/ Levels of Concern Once a pesticide’s toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/ safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect during a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/ pesticides/factsheets/riskassess.htm. A summary of the toxicological endpoints for sulfoxaflor used for human risk assessment is shown in the Table of this unit. E:\FR\FM\28SER1.SGM 28SER1 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations 59563 TABLE—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR SULFOXAFLOR FOR USE IN HUMAN HEALTH RISK ASSESSMENT Point of departure and uncertainty/ safety factors RfD, PAD, LOC for risk assessment Study and toxicological effects Acute dietary (Females 13–50 years of age). NOAEL = 1.8 mg/kg/ day. UFA = 3x ≤UFH = 10x ≤FQPA SF = 1x Acute RfD = 0.06 g/ kg/day. aPAD = 0.06 mg/kg/ day Developmental Neurotoxicity Study. LOAEL = 7.1 mg/kg/day based on decreased neonatal survival on postnatal day 0 through 4. Acute dietary (General population including infants and children). NOAEL = 25 mg/kg/ day. UFA = 10x UFH = 10x FQPA SF = 1x Acute RfD = 0.25 mg/kg/day. aPAD = 0.25 mg/kg/ day Acute Neurotoxicity Study. LOAEL = 75 mg/kg/day based on decreased motor activity. Chronic dietary (All populations) NOAEL = 5.13 mg/ kg/day. UFA = 10x UFH = 10x FQPA SF = 1x Chronic RfD = 0.05 mg/kg/day. cPAD = 0.05 mg/kg/ day Chronic/Carcinogenicity Study in the Rat. LOAEL = 21.3 mg/kg/ day based on liver effects including increased blood cholesterol, liver weight, hypertrophy, fatty change, single cell necrosis and macrophages observed in the males and females. Cancer (Oral, dermal, inhalation). Sulfoxaflor is classified as ‘‘Suggestive Evidence of Carcinogenic Potential.’’ Quantification of risk using a nonlinear approach (i.e., RfD) will adequately account for all chronic toxicity, including carcinogenicity. Exposure/scenario mstockstill on DSK4VPTVN1PROD with RULES UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. LOAEL = lowest observed adverse effect level. NOAEL = no observed adverse effect level. B. Exposure Assessment 1. Dietary exposure from food and feed uses. In evaluating dietary exposure to sulfoxaflor, EPA considered exposure under the time-limited tolerances established by this action. EPA assessed dietary exposures from sulfoxaflor in food as follows: i. Acute and Chronic exposure. Acute and chronic effects were identified for sulfoxaflor. In estimating acute and chronic dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994–1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). EPA’s dietary exposure assessment assumed that all cotton in the U.S. is treated with sulfoxaflor (i.e., 100% crop treated); an empirical factor of 0.1X to account for the reduction in sulfoxaflor residues during the processing of cottonseed into oil (which is the only human food associated with cotton); and used health-protective models to estimate residues in drinking water. ii. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a fooduse pesticide based on the weight of the evidence from cancer studies and other relevant data. Cancer risk may be quantified using a linear or nonlinear approach. If sufficient information is available to determine the carcinogenic mode of action, and that mode of action has a threshold, then EPA will use a threshold or nonlinear approach and VerDate Mar<15>2010 16:22 Sep 27, 2012 Jkt 226001 calculate a cancer RfD based on an earlier noncancer key event. If the mode of carcinogenic action is unknown, or if the mode of action appears to be mutagenic, a default linear cancer slope factor approach is utilized. Based on studies demonstrating key events of a hypothesized mode of action leading to the observed tumors and no mutagenicity concerns, EPA has concluded that a nonlinear RfD approach is appropriate for assessing cancer risk to sulfoxaflor. Cancer risk was assessed using the same exposure estimates as discussed in Unit IV.B.1.i., acute and chronic exposure. iii. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for sulfoxaflor. For this risk assessment, EPA assumed that all cottonseed oil contains tolerance level residues (modified by an empirical processing factor) and that 100% of cotton is treated with sulfoxaflor. 2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sulfoxaflor in drinking water. These simulation models take into account data on the physical, chemical, and fate/ transport characteristics of sulfoxaflor. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/ water/index.htm. PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI– GROW) models, the estimated drinking water concentrations (EDWCs) of sulfoxaflor for acute exposures are estimated to be 2.76 parts per billion (ppb) for surface water and 45.1 ppb for ground water; for chronic exposures for non-cancer assessments are estimated to be 0.865 ppb for surface water and 45.1 ppb for ground water. Environmental fate data indicate that the predominant residue in surface water will be the parent compound and the predominant residue in groundwater will be the X11719474 metabolite (88% of the total residue) and X11519450 (12% of the total residue). For convenience, EPA’s exposure assessment multiplies the relative toxicity of each metabolite by its proportion to express the residue concentration in terms of parent sulfoxaflor-equivalents. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 0.045 ppm (0.0397 ppm X11719474 + 0.0054 ppm X11519450) was used to assess the contribution of drinking water to dietary exposure for the general population, except women of child-bearing age (13– 49 years). For females 13–49 years old, the acute surface water EDWC (0.0028 ppm) was used to assess the contribution of drinking water. For E:\FR\FM\28SER1.SGM 28SER1 59564 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations mstockstill on DSK4VPTVN1PROD with RULES chronic dietary risk assessment for the general population, including females 13–49 years old, the ground water concentration of value 0.066 ppm was used to assess the contribution of drinking water. The groundwater value of 0.066 ppm reflects individual concentrations of X11719474 and X11519540, adjusted for their relative potencies of 0.3X and 10X, respectively. 3. From non-dietary exposure. The term ‘‘residential exposure’’ is used in this document to refer to nonoccupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Sulfoxaflor is currently not registered for any use that will result in residential exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at: http://www.epa.gov/ pesticides/trac/science/trac6a05.pdf. 4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ‘‘available information’’ concerning the cumulative effects of a particular pesticide’s residues and’’ other substances that have a common mechanism of toxicity.’’ EPA has not found sulfoxaflor to share a common mechanism of toxicity with any other substances, and sulfoxaflor does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that sulfoxaflor does not have a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA’s Web site at http:// www.epa.gov/pesticides/cumulative. available to EPA support the choice of a different factor. 2. Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity databases for sulfoxaflor are complete. Although adverse developmental effects were observed in rats, the mode of action is understood and does not appear relevant to humans. Data indicate that juvenile rats are uniquely sensitive to perturbation of the muscular nicotinic receptor by sulfoxaflor, leading to sustained muscle contraction and increased neonatal deaths. Supporting studies indicate that sulfoxaflor does not interact with nicotinic receptors in the adult rat, fetal human, or adult human. Furthermore, the observation that no neonatal deaths or neuromuscular/skeletal effects were noted in the rabbit developmental toxicity study supports the conclusion that rats are uniquely sensitive to developmental toxicity due to sulfoxaflor exposure. These differences suggest that to the extent that neonatal death in rats occurs as a result of sulfoxaflor binding to the fetal receptor, these effects would not be observed in humans. 3. Conclusion. EPA has determined that reliable data show that the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings: the level of concern for neurotoxicity is low because the effects are well characterized and clear NOAELs are established. Similarly, although there is increased quantitative susceptibility in the developmental neurotoxicity (DNT) study, the level of concern for the increased susceptibility is low because the effects are well characterized and the endpoints chosen for risk assessment are protective of potential in utero developmental effects. In addition, the exposure assessments are highly conservative and unlikely to underestimate exposure/risk. C. Safety Factor for Infants and Children 1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data D. Aggregate Risks and Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to VerDate Mar<15>2010 16:22 Sep 27, 2012 Jkt 226001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 sulfoxaflor will occupy 4% of the aPAD for infants (<1 year), the population group receiving the greatest exposure. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sulfoxaflor from food and water will utilize 9% of the cPAD for infants (<1 year)the population group receiving the greatest exposure. There are no residential uses for sulfoxaflor. 3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term adverse effect was identified; however, sulfoxaflor is not registered for any use patterns that would result in short-term residential exposure. Because there is no short-term residential exposure, sulfoxaflor poses no short-term risk. 4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, sulfoxaflor is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediateterm residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure, sulfoxaflor poses no intermediate-term risk. 5. Aggregate cancer risk for U.S. population. EPA determined that there is a ‘‘Suggestive Evidence of Carcinogenic Potential’’ for sulfoxaflor based on the preputial gland tumor response seen in rats. When there is suggestive evidence, the Agency does not attempt a dose-response assessment as the nature of the data generally would not support one. Rather, the Agency has determined that quantification of risk using a non-linear approach (i.e., reference dose (RfD) will adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to sulfoxaflor. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to sulfoxaflor residues. E:\FR\FM\28SER1.SGM 28SER1 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations V. Other Considerations VI. Conclusion A. Analytical Enforcement Methodology Therefore, time-limited tolerances are established for residues of, sulfoxaflor, N-methyloxido [1-[6-(trifluoromethyl)-3pyridinyl]ethyl] l4-sulfanylidene] cyanamide including its metabolites and degradates, in or on cotton, undelinted seed at 0.2 parts per million (ppm); cotton, ginbyproducts at 6.0 ppm; and cotton, hulls at 0.35 ppm. These tolerances expire on December 31, 2015. Adequate analytical methods have been submitted for both data collection and for enforcement purposes. In the submitted field trial and processing studies, residues of sulfoxaflor and its metabolites in crops were determined using 2 different Dow analytical methods (designated as 091031 or 091116). The proposed method for tolerance enforcement in plant commodities is method 091116: Enforcement Method for the Determination of Sulfoxaflor (XDE–208) and its Main Metabolites in Agricultural Commodities using Offline Solid-Phase Extraction and Liquid Chromatography with Tandem Mass Spectrometry Detection. Method 091116 extracts residues with acetonitrile/water and includes use of a deuterated internal standard, hydrolysis with NaOH to release base-labile conjugates, and clean up via solid-phase extraction. This method is applicable for the quantitative determination of residues of sulfoxaflor and its metabolites in agricultural commodities and processed products. The method was adequately validated, with a limit of quantitation (LOQ) of 0.010 mg/kg for all matrices. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755–5350; telephone number: (410) 305–2905; email address: residuemethods@epa.gov. mstockstill on DSK4VPTVN1PROD with RULES B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for sulfoxaflor. VerDate Mar<15>2010 16:22 Sep 27, 2012 Jkt 226001 VII. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ‘‘Regulatory Planning and Review’’ (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 59565 the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104–4). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104–113, section 12(d) (15 U.S.C. 272 note). VIII. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a ‘‘major rule’’ as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 20, 2012. Steven Bradbury, Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Section 180.668 is added to subpart C to read as follows: ■ § 180.668 residues. Sulfoxaflor; tolerances for (a) General. [Reserved] (b) Section 18 emergency exemptions. Time-limited tolerances specified in the following table are established for residues of the insecticide, sulfoxaflor, E:\FR\FM\28SER1.SGM 28SER1 59566 Federal Register / Vol. 77, No. 189 / Friday, September 28, 2012 / Rules and Regulations N-methyloxido [1-[6-(trifluoromethyl)-3pyridinyl]ethyl] l4-sulfanylidene] cyanamide, including its metabolites and degradates, in or on the commodities in the following table resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance with the tolerance levels specified in the following table is to be determined by measuring only sulfoxaflor in or on the commodity. The tolerances expire on the date specified in the table. Commodity mstockstill on DSK4VPTVN1PROD with RULES Cotton, undelinted seed .................... Cotton, gin byproducts ...................... Cotton, hulls ............ VerDate Mar<15>2010 (c) Tolerances with regional registrations. [Reserved] (d) Indirect or inadvertent residues. [Reserved] [FR Doc. 2012–23818 Filed 9–27–12; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration issue of Thursday, August 9, 2012, make the following correction: § 563.8 Data format On page 47557 in the table titled ‘‘Table III—Reported Data Element Format’’, in the ‘‘Accuracy 1’’ column, in the twenty-fifth row, ‘‘ ±ms’’ should read ‘‘ ±2ms’’. [FR Doc. C1–2012–19580 Filed 9–27–12; 8:45 am] BILLING CODE 1505–01–D 49 CFR Part 563 Parts per million Expiration date 0.2 12/31/15 Event Data Recorders 6.0 0.35 12/31/15 12/31/15 Correction In rule document 2012–19580, appearing on pages 47552–47557 in the 16:22 Sep 27, 2012 Jkt 226001 [Docket No. NHTSA–2012–0099] RIN 2127–AL14 PO 00000 Frm 00026 Fmt 4700 Sfmt 9990 [Corrected] E:\FR\FM\28SER1.SGM 28SER1

Agencies

[Federal Register Volume 77, Number 189 (Friday, September 28, 2012)]
[Rules and Regulations]
[Pages 59561-59566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23818]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0493; FRL-9361-4]


Sulfoxaflor; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of sulfoxaflor, N-methyloxido [1-[6-(trifluoromethyl)-3-
pyridinyl]ethyl] [lambda]\4\-sulfanylidene] cyanamide, including its 
metabolites and degradates in or on cotton, undelinted seed; cotton, 
gin byproducts; and cotton, hulls. This action is in response to EPA's 
granting of emergency exemptions under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of 
the pesticide on cotton. This regulation establishes maximum 
permissible levels for residues of sulfoxaflor in or on these 
commodities. These time-limited tolerances expire on December 31, 2015.

DATES: This regulation is effective September 28, 2012. Objections and 
requests for hearings must be received on or before November 27, 2012, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2012-0493, is available at http://www.regulations.gov or at the OPP Docket in the Environmental 
Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 
3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Libby Pemberton, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: 703-308-9364; email address: pemberton.libby@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2012-0493 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before November 27, 2012. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2012-0493, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statue.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 28221T, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.htm.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with FFDCA sections 
408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is 
establishing time-limited tolerances for combined residues of 
sulfoxaflor, N-methyloxido [1-[6-(trifluoromethyl)-3-pyridinyl]ethyl] 
[lambda]\4\-sulfanylidene] cyanamide, including its metabolites and 
degradates in or on cotton, undelinted seed at 0.2 parts per million 
(ppm); cotton, gin byproducts at 6.0 ppm; and cotton, hulls at 0.35 
ppm. These time-limited tolerances expire on December 31, 2015.
    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of FFDCA section 408 and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.''

[[Page 59562]]

Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there 
is a reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue, including all anticipated 
dietary exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue * * 
*.''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Sulfoxaflor for Various Commodities and 
FFDCA Tolerances

    The states of Arkansas, Mississippi, Tennessee, and Louisiana 
submitted emergency use requests for the use of the unregistered active 
ingredient, sulfoxaflor, on cotton to control the tarnished plant bug. 
The requests are a result of the resurgence of tarnished plant bug as a 
primary pest of cotton. The states assert growers are facing a longer 
control season for tarnished plant bug. In addition, tarnished plant 
bug has developed resistance to registered alternatives. After having 
reviewed the submissions, EPA determined that emergency conditions 
exist for these States, and that the criteria for emergency exemptions 
are met. EPA has authorized specific exemptions under FIFRA section 18 
for the use of sulfoxaflor on cotton for control of tarnished plant bug 
in Arkansas, Mississippi, Tennessee, and Louisiana.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of sulfoxaflor 
in or on cotton. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerance 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment as provided in FFDCA section 408(l)(6). Although 
these time-limited tolerances expire on December 31, 2015, under FFDCA 
section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerance remaining in or on cotton, 
undelinted seed; cotton, ginbyproducts; and cotton, hulls after that 
date will not be unlawful, provided the pesticide was applied in a 
manner that was lawful under FIFRA, and the residues do not exceed a 
level that was authorized by these time-limited tolerances at the time 
of that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
sulfoxaflor meets FIFRA's registration requirements for use on cotton 
or whether permanent tolerances for this use would be appropriate. 
Under these circumstances, EPA does not believe that these time-limited 
tolerances decision serves as a basis for registration of sulfoxaflor 
by a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance by itself serve as the authority for persons in any 
State other than Arkansas, Mississippi, Tennessee, and Louisiana to use 
this pesticide on the applicable crops under FIFRA section 18 absent 
the issuance of an emergency exemption applicable within that State. 
For additional information regarding the emergency exemption for 
sulfoxaflor, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of these emergency exemption requests and 
the time-limited tolerances for combined residues of sulfoxaflor in or 
on cotton, undelinted seed at 0.2 parts per million (ppm); cotton, gin 
byproducts at 6.0 ppm; and cotton, hulls at 0.35 ppm. Use of cotton 
commodities conforming to these temporary tolerances as animal feed is 
not expected to produce sulfoxaflor residues in livestock commodities. 
EPA's assessment of exposures and risks associated with establishing 
these time-limited tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect during a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sulfoxaflor used for 
human risk assessment is shown in the Table of this unit.

[[Page 59563]]



   Table--Summary of Toxicological Doses and Endpoints for Sulfoxaflor for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-50       NOAEL = 1.8 mg/kg/    Acute RfD = 0.06 g/  Developmental Neurotoxicity Study.
 years of age).                     day.                  kg/day.              LOAEL = 7.1 mg/kg/day based on
                                   UFA = 3x............  aPAD = 0.06 mg/kg/    decreased neonatal survival on
                                   >UFH = 10x..........   day.                 postnatal day 0 through 4.
                                   >FQPA SF = 1x.......
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  NOAEL = 25 mg/kg/day  Acute RfD = 0.25 mg/ Acute Neurotoxicity Study. LOAEL =
 including infants and children).  UFA = 10x...........   kg/day.              75 mg/kg/day based on decreased
                                   UFH = 10x...........  aPAD = 0.25 mg/kg/    motor activity.
                                   FQPA SF = 1x........   day.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 5.13 mg/kg/   Chronic RfD = 0.05   Chronic/Carcinogenicity Study in
                                    day.                  mg/kg/day.           the Rat. LOAEL = 21.3 mg/kg/day
                                   UFA = 10x...........  cPAD = 0.05 mg/kg/    based on liver effects including
                                   UFH = 10x...........   day.                 increased blood cholesterol,
                                   FQPA SF = 1x........                        liver weight, hypertrophy, fatty
                                                                               change, single cell necrosis and
                                                                               macrophages observed in the males
                                                                               and females.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Sulfoxaflor is classified as ``Suggestive Evidence of Carcinogenic
                                    Potential.'' Quantification of risk using a non-linear approach (i.e., RfD)
                                    will adequately account for all chronic toxicity, including carcinogenicity.
----------------------------------------------------------------------------------------------------------------
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members
  of the human population (intraspecies). FQPA SF = Food Quality Protection Act Safety Factor. PAD = population
  adjusted dose (a = acute, c = chronic). RfD = reference dose. LOAEL = lowest observed adverse effect level.
  NOAEL = no observed adverse effect level.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to sulfoxaflor, EPA considered exposure under the time-limited 
tolerances established by this action. EPA assessed dietary exposures 
from sulfoxaflor in food as follows:
    i. Acute and Chronic exposure. Acute and chronic effects were 
identified for sulfoxaflor. In estimating acute and chronic dietary 
exposure, EPA used food consumption information from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intake by Individuals (CSFII). EPA's dietary 
exposure assessment assumed that all cotton in the U.S. is treated with 
sulfoxaflor (i.e., 100% crop treated); an empirical factor of 0.1X to 
account for the reduction in sulfoxaflor residues during the processing 
of cottonseed into oil (which is the only human food associated with 
cotton); and used health-protective models to estimate residues in 
drinking water.
    ii. Cancer. EPA determines whether quantitative cancer exposure and 
risk assessments are appropriate for a food-use pesticide based on the 
weight of the evidence from cancer studies and other relevant data. 
Cancer risk may be quantified using a linear or nonlinear approach. If 
sufficient information is available to determine the carcinogenic mode 
of action, and that mode of action has a threshold, then EPA will use a 
threshold or nonlinear approach and calculate a cancer RfD based on an 
earlier noncancer key event. If the mode of carcinogenic action is 
unknown, or if the mode of action appears to be mutagenic, a default 
linear cancer slope factor approach is utilized. Based on studies 
demonstrating key events of a hypothesized mode of action leading to 
the observed tumors and no mutagenicity concerns, EPA has concluded 
that a nonlinear RfD approach is appropriate for assessing cancer risk 
to sulfoxaflor. Cancer risk was assessed using the same exposure 
estimates as discussed in Unit IV.B.1.i., acute and chronic exposure.
    iii. Anticipated residue and percent crop treated (PCT) 
information. EPA did not use anticipated residue and/or PCT information 
in the dietary assessment for sulfoxaflor. For this risk assessment, 
EPA assumed that all cottonseed oil contains tolerance level residues 
(modified by an empirical processing factor) and that 100% of cotton is 
treated with sulfoxaflor.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for sulfoxaflor in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of sulfoxaflor. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
sulfoxaflor for acute exposures are estimated to be 2.76 parts per 
billion (ppb) for surface water and 45.1 ppb for ground water; for 
chronic exposures for non-cancer assessments are estimated to be 0.865 
ppb for surface water and 45.1 ppb for ground water. Environmental fate 
data indicate that the predominant residue in surface water will be the 
parent compound and the predominant residue in groundwater will be the 
X11719474 metabolite (88% of the total residue) and X11519450 (12% of 
the total residue). For convenience, EPA's exposure assessment 
multiplies the relative toxicity of each metabolite by its proportion 
to express the residue concentration in terms of parent sulfoxaflor-
equivalents.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 0.045 ppm (0.0397 ppm 
X11719474 + 0.0054 ppm X11519450) was used to assess the contribution 
of drinking water to dietary exposure for the general population, 
except women of child-bearing age (13-49 years). For females 13-49 
years old, the acute surface water EDWC (0.0028 ppm) was used to assess 
the contribution of drinking water. For

[[Page 59564]]

chronic dietary risk assessment for the general population, including 
females 13-49 years old, the ground water concentration of value 0.066 
ppm was used to assess the contribution of drinking water. The 
groundwater value of 0.066 ppm reflects individual concentrations of 
X11719474 and X11519540, adjusted for their relative potencies of 0.3X 
and 10X, respectively.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Sulfoxaflor is 
currently not registered for any use that will result in residential 
exposure. Further information regarding EPA standard assumptions and 
generic inputs for residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and'' other substances 
that have a common mechanism of toxicity.''
    EPA has not found sulfoxaflor to share a common mechanism of 
toxicity with any other substances, and sulfoxaflor does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
sulfoxaflor does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional SF when reliable data 
available to EPA support the choice of a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicity databases for sulfoxaflor are complete. Although adverse 
developmental effects were observed in rats, the mode of action is 
understood and does not appear relevant to humans. Data indicate that 
juvenile rats are uniquely sensitive to perturbation of the muscular 
nicotinic receptor by sulfoxaflor, leading to sustained muscle 
contraction and increased neonatal deaths. Supporting studies indicate 
that sulfoxaflor does not interact with nicotinic receptors in the 
adult rat, fetal human, or adult human. Furthermore, the observation 
that no neonatal deaths or neuromuscular/skeletal effects were noted in 
the rabbit developmental toxicity study supports the conclusion that 
rats are uniquely sensitive to developmental toxicity due to 
sulfoxaflor exposure. These differences suggest that to the extent that 
neonatal death in rats occurs as a result of sulfoxaflor binding to the 
fetal receptor, these effects would not be observed in humans.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings: the level of concern for neurotoxicity is low because the 
effects are well characterized and clear NOAELs are established. 
Similarly, although there is increased quantitative susceptibility in 
the developmental neurotoxicity (DNT) study, the level of concern for 
the increased susceptibility is low because the effects are well 
characterized and the endpoints chosen for risk assessment are 
protective of potential in utero developmental effects. In addition, 
the exposure assessments are highly conservative and unlikely to 
underestimate exposure/risk.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the appropriate PODs to ensure 
that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to sulfoxaflor will occupy 4% of the aPAD for infants (<1 year), the 
population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
sulfoxaflor from food and water will utilize 9% of the cPAD for infants 
(<1 year)the population group receiving the greatest exposure. There 
are no residential uses for sulfoxaflor.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). A short-term 
adverse effect was identified; however, sulfoxaflor is not registered 
for any use patterns that would result in short-term residential 
exposure. Because there is no short-term residential exposure, 
sulfoxaflor poses no short-term risk.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term non-dietary, non-occupational 
exposure plus chronic exposure to food and water (considered to be a 
background exposure level).
    An intermediate-term adverse effect was identified; however, 
sulfoxaflor is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure, sulfoxaflor poses no intermediate-term risk.
    5. Aggregate cancer risk for U.S. population. EPA determined that 
there is a ``Suggestive Evidence of Carcinogenic Potential'' for 
sulfoxaflor based on the preputial gland tumor response seen in rats. 
When there is suggestive evidence, the Agency does not attempt a dose-
response assessment as the nature of the data generally would not 
support one. Rather, the Agency has determined that quantification of 
risk using a non-linear approach (i.e., reference dose (RfD) will 
adequately account for all chronic toxicity, including carcinogenicity, 
that could result from exposure to sulfoxaflor.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to sulfoxaflor residues.

[[Page 59565]]

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate analytical methods have been submitted for both data 
collection and for enforcement purposes. In the submitted field trial 
and processing studies, residues of sulfoxaflor and its metabolites in 
crops were determined using 2 different Dow analytical methods 
(designated as 091031 or 091116). The proposed method for tolerance 
enforcement in plant commodities is method 091116: Enforcement Method 
for the Determination of Sulfoxaflor (XDE-208) and its Main Metabolites 
in Agricultural Commodities using Offline Solid-Phase Extraction and 
Liquid Chromatography with Tandem Mass Spectrometry Detection. Method 
091116 extracts residues with acetonitrile/water and includes use of a 
deuterated internal standard, hydrolysis with NaOH to release base-
labile conjugates, and clean up via solid-phase extraction. This method 
is applicable for the quantitative determination of residues of 
sulfoxaflor and its metabolites in agricultural commodities and 
processed products. The method was adequately validated, with a limit 
of quantitation (LOQ) of 0.010 mg/kg for all matrices. The method may 
be requested from: Chief, Analytical Chemistry Branch, Environmental 
Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone 
number: (410) 305-2905; email address: residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for sulfoxaflor.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of, 
sulfoxaflor, N-methyloxido [1-[6-(trifluoromethyl)-3-pyridinyl]ethyl] 
[lambda]\4\-sulfanylidene] cyanamide including its metabolites and 
degradates, in or on cotton, undelinted seed at 0.2 parts per million 
(ppm); cotton, ginbyproducts at 6.0 ppm; and cotton, hulls at 0.35 ppm. 
These tolerances expire on December 31, 2015.

VII. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA sections 408(e) 
and 408(l)(6). The Office of Management and Budget (OMB) has exempted 
these types of actions from review under Executive Order 12866, 
entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 
1993). Because this final rule has been exempted from review under 
Executive Order 12866, this final rule is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with FFDCA sections 408(e) and 408(l)(6), such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VIII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: September 20, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.


0
2. Section 180.668 is added to subpart C to read as follows:


Sec.  [emsp14]180.668  Sulfoxaflor; tolerances for residues.

    (a) General. [Reserved]
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
insecticide, sulfoxaflor,

[[Page 59566]]

N-methyloxido [1-[6-(trifluoromethyl)-3-pyridinyl]ethyl] [lambda]\4\-
sulfanylidene] cyanamide, including its metabolites and degradates, in 
or on the commodities in the following table resulting from use of the 
pesticide pursuant to FIFRA section 18 emergency exemptions. Compliance 
with the tolerance levels specified in the following table is to be 
determined by measuring only sulfoxaflor in or on the commodity. The 
tolerances expire on the date specified in the table.

------------------------------------------------------------------------
                                                   Parts per  Expiration
                    Commodity                       million       date
------------------------------------------------------------------------
Cotton, undelinted seed.........................        0.2     12/31/15
Cotton, gin byproducts..........................        6.0     12/31/15
Cotton, hulls...................................        0.35    12/31/15
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-23818 Filed 9-27-12; 8:45 am]
BILLING CODE 6560-50-P